Craif Raises $33M Series D to Bring Urine-Based AI Cancer Test to the U.S.

Craif Inc. (搜索)搜索该词条, a Tokyo-based bio-AI company, has closed an approximately $33 million Series D round to accelerate the introduction of its urine-based cancer detection test to the United States. The financing brings the company's total capital raised since its 2018 founding to roughly $88 million, and will support U.S. research and development, a reimbursement-driven launch of its non-invasive cancer test, and a Japanese regulatory filing for a software-based medical device (SaMD) program targeting pancreatic cancer (搜索)搜索该疾病 diagnosis.

The round was co-led by Granite-Integral (搜索)搜索该词条, a joint venture between Granite Asia and Integral Corporation, and by Tauns Co., Ltd. (搜索)搜索该词条, one of Japan's largest makers of rapid diagnostic tests. Granite Asia is a Singapore-based investment platform managing about $10 billion across the Asia-Pacific region, while Integral Corporation manages approximately $3 billion and was the first Japanese private equity firm to list on the Tokyo Stock Exchange. U.S.-based Unreasonable and existing investor X&KSK also participated, alongside institutional and individual investors across Singapore, the United States and Japan. The round comprised approximately $30.7 million in equity and approximately $3.3 million in debt, and included a secondary transaction of about ¥900 million.

A urine-based platform for early cancer detection

Founded in Japan in 2018, Craif developed a urine-based cancer detection platform that uses artificial intelligence to analyze microRNA (搜索)搜索该靶点 — small regulatory molecules whose discovery and biological significance were recognized by the 2024 Nobel Prize in Physiology or Medicine. Its flagship test, miSignal (搜索)搜索该药品, evaluates risk for 10 cancer types, including pancreatic cancer (搜索)搜索该疾病, from stage 1, and is offered at more than 2,500 medical institutions and 4,500 pharmacies across Japan, with over 110,000 tests performed to date. Craif has published more than 90 peer-reviewed papers and conference presentations, including two independent publications demonstrating the early and accurate detection of pancreatic cancer.

The company's approach stands apart in the multi-cancer early detection (MCED) market, where most approaches rely on blood tests. Craif's urine-based method is designed to support early cancer detection and a broader urine-analysis platform.

Building a U.S. clinical team

A key component of Craif's plans is scaling R&D at its newly opened San Diego laboratory, including a prospective clinical study of its urine-based test in pancreatic cancer (搜索)搜索该疾病 — an indication where, according to the company, the clinical utility and the path to reimbursement are clear. A simple, non-invasive urine test could help clinicians decide who needs further workup and who can safely wait.

To spearhead that work, Craif has appointed Nicholas (Nick) Bevins, MD, PhD, as chief medical officer. Dr. Bevins will lead the company's clinical development strategy to build the body of evidence necessary to meet reimbursement and regulatory requirements. He holds a bachelor's degree in biochemistry from Columbia University, an MD and a PhD in neuroscience from the University of California, San Diego, and completed a residency in clinical pathology and laboratory medicine. A board-certified clinical pathologist, he has served as both chief medical officer and CLIA laboratory director at several biotechnology and diagnostics companies. Because offering laboratory-developed tests in the United States requires a CLIA-certified laboratory under the oversight of a qualified laboratory director, Dr. Bevins brings a rare combination of that qualification and executive responsibility for clinical and regulatory strategy.

His appointment further accelerates Craif's strategic expansion as it now advances partnerships with 30 medical institutions across 15 states. The company established a U.S. subsidiary in 2022 and joined the JLABS incubator. In April 2026, Craif opened its bio-AI laboratory in San Diego, and CEO Ryuichi Onose relocated there to lead the U.S. business. Chief Financial Officer Takeo Mukai, who previously held finance and operating leadership roles at Medtronic and several U.S. healthcare companies, also joined this year as a local hire.

Leadership perspectives

"Cancer screening should be as simple as a routine check-up, not a procedure patients avoid," said CK Chuon, Partner & Co-Head of Granite-Integral (搜索)搜索该词条. "Craif has proven in Japan that a non-invasive urine test can detect cancer early and at scale, and we believe the same approach can unlock massive unmet demand in the United States."

CEO and co-founder Ryuichi Onose framed the company's broader ambition: "What we are building goes beyond a single cancer test. The earliest signals of many diseases show up in urine, and reading them is what Craif is really about. Cancer is the first step."

Dr. Bevins added: "I joined Craif because the company has built a differentiated platform, generated an extraordinary body of clinical evidence in Japan, and is committed to advancing science through rigorous data rather than hype. Urine will play an increasingly important role in the future of early disease detection because it offers a non-invasive window into human biology."

Masataka Nonaka, President & Representative Director of TAUNS Laboratories, Inc., noted that as one of Craif's distribution partners for miSignal (搜索)搜索该药品, TAUNS expects the funding to move both miSignal and the pancreatic cancer (搜索)搜索该疾病 SaMD program now in development closer to real-world clinical use.